Abstract: :
Purpose: ASED have been used in the treatment of severe dryeye–disease. We have evaluated the efficacy of undiluted(ud) ASED compared to a 50% concentration (di) of ASED for refractorydry eye–syndrome in a prospective, randomized and double–blindfashion. Here, we present our 3–months–results ofan ongoing study.Methods: Patients fulfilling ophthalmological and medical entrycriteria were randomized to 3 months of udASED and diASED (1:1in sodium chloride) to the right or left eye, respectively.Clinical assessment, including Schirmer’s test, break–uptime, and fluorescein staining was performed at baseline, 2weeks, 2 and 3 months. Examination and grading was carried outby two ophthalmologists. Subjective comfort and improvementwas recorded during each visit using the ‘‘faces’’–scale(FS; 7 grades with 1 being best and 7 worst). Results are presentedas the arithmetic mean.Results: Eleven patients were enrolled into the study, and 16eyes from 8 patients could be evaluated so far. Eight eyes weretreated with diASED and 8 eyes with udASED. Baseline resulton the FS was in average 5.63 for udASED and 5.25 for diASED.The FS showed improvement in 14 eyes after the first 2 weeks:eyes treated with udASED improved by 1.5 (to 4.13), and eyeswith diASED by 1.38 (to 4). The results of the 2 months’visit included 10 eyes of 5 patients. Compared to the baselineresults there was a decrease by 3 (to 2.75) in the eyes treatedwith udASED and by 2.4 (to 3) in the eyes with diASED. After3 months, no obvious further improvement was seen ("face"–score2.75 in 4 eyes with udASED and 3 in 4 eyes with diASED). Objectiveclinical criteria did not correlate well with the FS but alsoimproved based on an obvious reduction of corneal staining,conjunctival folds and hyperemia.Conclusions: The results provide further evidence for the beneficialeffects of ASED in dry eye–syndrome. Within the first2 weeks of treatment there was a distinct increase in subjectivecomfort for both diASED and udASED. This improvement continuedduring the first 2 months and remained stable during the lastmonth. Although udASED showed only little numerical improvementcompared to diASED, most patients preferred the use of udASED.In general, ASED was considered superior to conventional treatmentfor improving ocular surface health and subjective comfort.